MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-18 for TISCHLEY BPSY FCPS 9-1/4IN WITH LOCK 301442WL manufactured by Integra York, Pa Inc..
[26438203]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[26438204]
Customer initially reports device was sticking in place during procedures. (b)(6) 2015 customer reports that - "our first time using the new tischler, doctor tried to biopsy patient. The forcep would not clamp down and he was unable to get a good biopsy because he couldn't separate the tissue from the cervix. Doctor had to manually open the tischler with the handle and another tischler was used for the biopsy. The device will not open on its own. It was uncomfortable for the patient during the process.
Patient Sequence No: 1, Text Type: D, B5
[34090954]
On 11/11/2015 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - failure analysis cannot be completed due to the lack of information received to perform a complete investigation. Product has not been returned for evaluation. Device history evaluation - dhr review. Nonconforming product report / nonconforming material report history: there is no applicable nonconforming product report / nonconforming material report history. Variance authorization / deviation history: there is no applicable variance authorization / deviation history. Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history. Corrective action preventive action history: none. Health hazard evaluation history: none. Conclusion: root cause cannot be determined due to the lack of information received to perform a complete investigation. Product has not been returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2015-00094 |
| MDR Report Key | 5089090 |
| Date Received | 2015-09-18 |
| Date of Report | 2015-09-15 |
| Date of Event | 2015-09-02 |
| Date Mfgr Received | 2015-11-11 |
| Date Added to Maude | 2015-09-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TISCHLEY BPSY FCPS 9-1/4IN WITH LOCK |
| Generic Name | PFM07 |
| Product Code | HFB |
| Date Received | 2015-09-18 |
| Catalog Number | 301442WL |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-18 |